Taking On A Giant

The tale of a committed group of health professionals who set stunning legal precedents, despite insurmountable odds, to force policy change

By Cindy Campbell, RN, MScAH, CGN(c)

On September 6th, 2018 the Ontario Nurses’ Association (ONA) announced they won a second arbitration on the influenza vaccinate or mask (VOM) policy, striking down the policy at St. Michael’s Hospital and several others that form the Toronto Academic Health Science Network (TAHSN).

VOM policies require staff be vaccinated against influenza or wear a mask. Those who refused were subject to suspension or termination. Besides the province of British Columbia (B.C.), VOM policies are not provincially mandated, but were implemented at several healthcare facilities across Canada. B.C’s Health Services Union challenged the VOM policy but lost a 2013 union arbitration which the B.C nurses’ union promise to take back to court armed with renewed evidence, witnesses and legal findings.

Arbitrator James Hayes struck down the VOM policy in a 2015 arbitration involving a Sault Ste. Marie Hospital. Hayes found “scant evidence” on asymptomatic viral shed or that masks reduced influenza transmission to patients. In light of the Hayes finding, more Ontario Hospitals withdrew VOM policies as did the province of Saskatchewan. In addition, Infection Protection and Control Canada (IPAC) pulled their support of mandatory healthcare worker influenza vaccination. Yet, several TAHSN hospitals blatantly refused to comply and continued to enforce a policy virtually identical to the one deemed “unreasonable” by Hayes. As a result, ONA was again forced to litigate St. Michael’s Hospital.

Tax payer funds were misdirected by St. Michael’s hospital to litigate this second arbitration, assessed by Arbitrator William Kaplan (2018) as “by and large, the same policy, the same legal issues and some of the very same evidence”. In his final summation, Arbitrator Kaplan deemed St. Michael’s /TAHSN policy was “illogical and makes no sense” and ” the exact opposite of being reasonable.” In reaching his conclusion, Arbitrator Kaplan noted St Michaels could provide no evidence that VOM reduced influenza outbreaks. He found “there is little evidence of any positive impact on patient care outcomes as a result of the VOM policy” and noted influenza outbreaks continued regardless. Arbitrator Kaplan also confirmed surveillance data from B.C. could not prove the policy objective of influenza control was met. In fact, under the VOM policy, in 2014/15 and 2015/16 B.C saw the most influenza outbreaks in long term care in a decade despite record numbers of flu vaccinated healthcare workers.

To date, mandatory influenza vaccination programs are considered a success based on increased vaccine rates alone, not clinical outcomes. A systematic review of mandatory influenza vaccination of healthcare workers from Johns Hopkins researchers (Pitt et al., 2014) revealed not a single mandatory influenza vaccination program tracked clinical benefits, despite being in existence since 2006. The authors concluded: “Evidence from observational studies suggests that a vaccine mandate increases vaccination rates, but evidence on clinical outcomes is lacking.”

A systematic review commissioned by the CDC (Ahmed et al., 2012), embraced by pro VOM officials found, “low or very low levels of evidence” for the outcomes that matter the most—lab-confirmed flu and flu hospitalizations. Since 2006, the prestigious Cochrane have concluded the evidence to support healthcare worker (HCW) influenza vaccination is methodologically flawed and cannot support that vaccinating staff protects patients from influenza or hospitalization related to influenza. The Lancet Infectious Disease meta-analysis (Osterholme et al.,2012) examined 5707 influenza studies over 40 years and could list only 31 conducted with proper scientific acumen. This list did not include the 4 Randomized Controlled Trials (RCT) which single handedly drove HCW vaccination mandates.

The 2018 Kaplan arbitration hearing included testimony from expert witnesses including Dr. Gaston DeSerres, Medical Epidemiologist at the Public Health Institute of Quebec and Dr. Micheal Gardam, Director of Infection Prevention and Control, University Health Network. Both were among a collection of top Canadian and world researches who wrote a 2017 Critical Analysis of the four aforementioned RCTS (DeSerres et al., 2017). Their analysis concluded: “The impression that unvaccinated HCWs place their patients at great influenza peril is exaggerated.” They found these four RCTS had “implausible results.” Regarding Dr DeSerres testimony, Kaplan summarized “I accept his evidence that the four RCTs provide impossible results from methodologically flawed studies that cannot reasonably be extrapolated and applied to an acute care setting.”

Kaplan, disregarded testimony of the St. Michaels/TASHN expert witnesses noting: “More seriously, some of the expert evidence advanced by St. Michael’s was particularly problematic and actually inconsistent with the most basic academic norms.” He found glaring errors including incorrect, overstated and unsupported propositions which led him to conclude “Everyone makes mistakes, but this went beyond the pale. I completely disregard their report. Kaplan went on to say “All of this evidence –really absence of evidence – goes to the heart of reasonableness.”

Alarmingly, it is “experts”, the likes admonished by Arbitrator Kaplan, who can and do hold pivotal health policy advisory roles; risking “illogical” health policy, based upon selective, inadequate evidence. During testimony from the 2015 Hayes arbitration Dr. Michael Gardam revealed the glaring exclusion of informed experts with alternate viewpoints during the construction of TAHSN’s VOM policy. Dr. Gardam testified such TASHN infectious disease experts were knowingly excluded from VOM committee meetings. He testified “Dr. McGeer was solely relied upon to translate the evidence for the other members of the committee, few of whom had the requisite training to understand or critique the complexities. Any scientific questions that arose were directed exclusively to Dr. McGeer to answer from her authoritative position”

Mandeville et al (2013) found academics such as Dr. McGeer, with ties to the pharmaceutical industry, use their “unique and powerful positions” to give increased risk assessments when serving in advisory roles, compared with un-conflicted academics. Academics with competing interests were found to alter public perception, overstate risks, and elevate public anxiety and the demand for new drugs and policy decisions.

However, the tone of several Canadian experts support of the flu vaccine appears to be waning. The Chief Officer of Health of Canada (Dr. Tam) and Dr. Skowronski, Lead Influenza Researcher of the Canadian CDC, have joined the list of others such a Dr. Richard Schabas (former Chief officer of Health of Ontario) who admit the flu vaccine is best for vulnerable populations only. The façade of protection offered by the flu vaccine appears to be cracking and it is no wonder. This is a vaccine with a yearly average efficacy of barely 35% over the past decade, largely incapable of combating the most virulent strain of influenza (H3N2), has been linked to concerning consequences of reduced immune responses with repeat vaccination, significantly higher amounts of viral shed among vaccinated populations (Yan et al, 2018).

Sadly, had it not been for a union with deep pockets and an unparalleled commitment to justice this policy would have continued as it does in B.C. and across the United States. Canadians can be proud of the integrity and bravery of true purveyors of science and sound patient care policy who worked with ONA such as heroes Dr. DeSerres and Dr. Gardam (just to name a few). Together with HCWs across Canada who raised their voices and endured the stigma and discomfort of wearing a mask, they have set an astounding precedent; for this was a collaborative effort of David and Goliath proportions. Intelligent Ontario healthcare professionals capable of delivering a baby and restarting your heart can now make a decision without coercion about how to best protect patients in their care from influenza. There are numerous ways to combat influenza, a controversial vaccine of unreliable predictability is but only one of them.